Whether respondents have Article III standing to challenge FDA's 2016 and 2021 actions

QUESTIONS PRESENTED This case concerns mifepristone, a drug that the U.S. Food and Drug Administration (FDA) approved in 2000 as safe and effective for terminating early pregnancies. The Fifth Circuit held that respondents—doctors and associations of doctors who oppose abortion—have Article III standing to challenge FDA’s 2016 and 2021 actions with respect to mifepristone’s approved conditions of use and that those actions were likely arbitrary and capricious. The court therefore affirmed the district court’s stay of the relevant agency actions. The questions presented are: 1. Whether respondents have Article III standing to challenge FDA’s 2016 and 2021 actions. 2. Whether FDA’s 2016 and 2021 actions were arbitrary and capricious. 3. Whether the district court properly granted preliminary relief. (I)